New chemicals and vaccines are effectively put on probation for up to two years and labelled with a black triangle to ensure prescribers are aware of the need to monitor them carefully. The black triangle symbol accompanies new medicines and vaccines in prescribing manuals, product information, and advertising material. It prompts healthcare professionals to report any potential side effects to the MHRA. This information helps to build up a broader picture of how the treatment works in the general population and enables the MHRA to act promptly, should a previously unrecognised and serious side effect come to light. The black triangle may also be assigned to a medicine that has already been licensed if it contains a new combination of active chemicals or if it is being used in a new way or for a different condition. The black triangle is not removed until the MHRA is satisfied that the medicine works safely in large numbers of people. Additionally, the MHRA also asks manufacturers to keep a close watch on side effects that may be associated with newly marketed products.
There is widespread confusion between the roles of MHRA and NICE (the National Institute for Health and Clinical Excellence). MHRA is concerned about the relationships between benefits and risks; NICE is conc erned, inter alia, about the relationships between benefits and costs. As a considerable over-simplification, MHRA says a product can be sold while NICE says it can be bought (by the NHS).
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